Percutaneous tibial nerve stimulator

ABSTRACT

A tibial nerve stimulation device including a percutaneous electrode for inserting adjacent a stimulation site of a patient and a neurostimulator unit attachable to a transcutaneous electrode configured to be applied to skin adjacent the stimulation site. The neurostimulator unit includes a pulse generator electrically coupled to the percutaneous needle electrode and transcutaneous electrode and a microcontroller in communication with the pulse generator for monitoring a number of available treatment credits and activating the pulse generator, each available treatment credit corresponding to a treatment session and the pulse generator operable to be activated for performing the treatment session when the number of available treatment credits is at least one. A computer system is operable to communicate with the microcontroller of the neurostimulator unit for receiving a treatment credit request and transmitting the number of treatment credits purchased to the microcontroller of the neurostimulator unit.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application Ser.No. 61/497,570 filed Jun. 16, 2011, and entitled “Percutaneous TibialNerve Stimulator,” the contents of which are incorporated by referenceherein in its entirety.

FIELD

This disclosure relates to the field of nerve stimulators. Moreparticularly, this disclosure relates to a percutaneous tibial nervestimulator device for treating urinary symptoms and a system forproviding payment for use of the device on a per-treatment sessionbasis.

BACKGROUND

Nerve and muscle stimulation are used to treat a variety of medicalconditions such as to reduce pain and to assist muscle and jointrehabilitation. Nerve stimulation has also been used for decades tocontrol bladder function. Various approaches to bladder neuromodulationhave been studied with stimulation of the pudendal, sacral, and tibialnerves found to be effective in controlling bladder function.

Percutaneous tibial nerve stimulation is a uniquely effective therapyfor treating overactive bladder (OAB) and the associated symptoms offrequency, urgency, and urinary urge incontinence. It is a minimallyinvasive neuromodulation delivery method performed by placing apercutaneous needle electrode in the proximity of the tibial nerve,i.e., the stimulation site. A pulse generator and a transcutaneouselectrode are electrically coupled to the needle electrode for providingcurrent pulses to the stimulation site by passing current from thetranscutaneous electrode to the percutaneous electrode.

One type of percutaneous tibial nerve stimulation system is described inU.S. Pat. No. 6,493,588 and is incorporated herein by reference. Thesystem described in the '588 patent includes a pulse generator, a firstlead wire electrically coupled to the pulse generator, a transcutaneouselectrode electrically coupled to the first lead wire, a second leadwire electrically coupled to the pulse generator, and a percutaneouselectrode needle electrically coupled to the second lead wire. Duringtreatment, the transcutaneous electrode is positioned distal from theselected stimulation site on the surface of the skin. The percutaneouselectrode needle is inserted through the skin in proximity of the tibialnerve. Current pulses traverse the internal stimulation site by passingfrom the transcutaneous electrode to the internal percutaneous electrodeneedle.

One problem with the system of the '588 patent was that the owners havehad trouble implementing the system into a financially viable andprofitable business model. In an attempt to solve this problem, thereusable lead wire system as described in the '588 patent was convertedinto a single use lead system as described, for example, in U.S. Pat.No. 7,536,226 and U.S. Pat. No. 8,046,082. While the advent of thesingle use lead system provides the ability to charge a patient/healthcare professional on a “per-treatment session” basis by requiring a newlead set to be used during each treatment session, the system requiresperfectly operating leads to be wasted which leads to additional costsfor the patient and manufacturer of the system. Further, the single uselead system is unable to determine whether a treatment session has beencompleted. Thus, if the treatment session was interrupted for anyreason, the single use lead set would have to be replaced with a newlead set.

Another problem that exists with the Uroplasty devices is that the unitis bulky and requires two lengthy leads for connecting the electrodes toa hand-held controller unit.

What is needed therefore is a percutaneous tibial nerve stimulatorsystem having reusable leads which provides the ability to charge apatient for each treatment session. In addition, a more compact and userfriendly percutaneous tibial nerve stimulator system is desired.

SUMMARY

A nerve stimulation system is disclosed including a neurostimulator unithaving a pulse generator for electrically coupling to a percutaneousneedle electrode and a transcutaneous electrode. The percutaneous needleelectrode has a leading end for inserting adjacent a stimulation site ofa patient and the transcutaneous electrode is configured to be appliedto skin adjacent the stimulation site of the patient. A microcontrolleris in communication with the pulse generator for monitoring a number ofavailable treatment credits and activating the pulse generator, eachavailable treatment credit corresponding to a treatment session and thepulse generator operable to be activated for performing the treatmentsession when the number of available treatment credits is at least one.During the treatment session, the pulse generator generates currentpulses that pass between the transcutaneous electrode and thepercutaneous needle electrode for providing stimulation to thestimulation site. A computer system is operable to communicate with themicrocontroller of the neurostimulator unit. The computer system isoperable to receive a treatment credit request having purchaseinformation including a number of treatment credits purchased, eachtreatment credit purchased corresponding to an available treatmentcredit, and transmitting the number of treatment credits purchased tothe microcontroller of the neurostimulator unit.

According to some embodiments, the computer system includes a customerinterface for submitting the treatment credit request. Theneurostimulator unit is preferably dimensioned and configured to beremoveably attached to the transcutaneous electrode.

In certain embodiments, each treatment credit purchased includes aunique serial number, the microcontroller being operable to transmitusage information to the computer system for monitoring usage of thepurchased treatment credits by the neurostimulator unit based on theunique serial numbers. The neurostimulator unit may be linked to aunique identification number and the purchase information of thetreatment credit request includes the unique identification number forauthorizing the transmission of the number of treatment creditspurchased to the microcontroller of the neurostimulator unit.

According to some embodiments, the treatment credit request may betransferred from the computer system to a portable digital storagedevice, the portable storage device connectable to the neurostimulatorunit for transmitting the number of treatment credits purchased to themicrocontroller of the neurostimulator unit. In other embodiments, thecomputer system communicates with the microcontroller of theneurostimulator unit wirelessly through one of radio frequency,Bluetooth, infrared, and a wireless internet connection. The computersystem may also communicate with the microcontroller of theneurostimulator unit through a universal serial bus connection.

According to another embodiment of the disclosure, a nerve stimulationsystem includes a plurality of neurostimulator units. Eachneurostimulator unit includes a unique identification number foridentifying the neurostimulator unit, a pulse generator operable to beelectrically coupled to a plurality of electrodes configured to beapplied adjacent a stimulation site of a patient, and a microcontrollerin communication with the pulse generator for monitoring a number ofavailable treatment credits and activating the pulse generator, eachavailable treatment credit corresponding to a treatment session and thepulse generator operable to be activated for performing the treatmentsession when the number of treatment credits available is at least one,the pulse generator generating current pulses during the treatmentsession that pass between the plurality of electrodes for providingstimulation to the stimulation site. A computer system receives atreatment credit request having purchase information including theunique identification number of one of the plurality of neurostimulatorunits and a number of treatment credits purchased, each treatment creditpurchased corresponding to an available treatment credit, the computersystem being operable to communicate with the microcontroller of theneurostimulator units for transmitting the purchase information to anappropriate neurostimulator unit based on the unique identificationnumber included in the purchase information.

According to some embodiments, each unique identification number islinked to at least one customer account and the computer system includesa customer interface for accessing the customer account and submittingthe treatment credit request.

According to yet another embodiment of the disclosure, a method forproviding a reusable nerve stimulation system to treat incontinence isdisclosed. The method includes the following steps: providing a computersystem having a customer interface; providing a neurostimulator unitincluding: a pulse generator for electrically coupling to atranscutaneous electrode configured to be applied to skin adjacent thestimulation site of a patient and a percutaneous electrode having aleading end for inserting adjacent a stimulation site of a patient, anda microcontroller in communication with the pulse generator formonitoring a number of available treatment credits to theneurostimulator unit and for activating the pulse generator during atreatment session when the number of available treatment credits is atleast one; receiving at the computer system a treatment credit requesttransmitted through the customer interface, each treatment creditrequest having purchase information including a number of treatmentcredits purchased, each treatment credit purchased corresponding to anavailable treatment credit; transmitting the number of treatment creditspurchased to the microcontroller of the neurostimulator unit; andadjusting the number of treatment credits available to theneurostimulator unit based on the number of treatment credits purchasedtransmitted to the microcontroller of the neurostimulator unit.

According to some embodiments, the method further includes determiningwhether the number of available treatment credits is at least one; andactivating the pulse generator based on a treatment session request whenit is determined that the number of available treatment credits is atleast one.

In certain embodiments, the method further includes transmitting usageinformation from the microcontroller to the computer system, the usageinformation including a number of treatment sessions performed;monitoring the usage information of the neurostimulator unit through thecomputer system; and providing the usage information to a customerthrough a customer interface of the computer system.

According to some embodiments, method further includes providing eachtreatment credit purchased with a unique serial number; monitoring usageinformation of each treatment credit purchased at the neurostimulatorunit; transmitting the usage information from the neurostimulator unitto the computer system for each treatment credit purchased based on theunique serial number.

BRIEF DESCRIPTION OF THE DRAWINGS

Further advantages of the disclosure are apparent by reference to thedetailed description in conjunction with the figures, wherein elementsare not to scale so as to more clearly show the details, wherein likereference numbers indicate like elements throughout the several views,and wherein:

FIG. 1 is a view of the tibial nerve stimulation device applied to thepatient according to one embodiment of the disclosure;

FIG. 2 is a front view of a neurostimulator unit according to oneembodiment of the disclosure;

FIG. 3 is a rear view of a neurostimulator unit according to oneembodiment of the disclosure;

FIG. 4 is a front view of a transcutaneous electrode patch according toone embodiment of the disclosure;

FIG. 5 is a block diagram of the internal circuitry of a neurostimulatorunit according to one embodiment of the disclosure;

FIG. 6 is a view of a customer interface according to one embodiment ofthe disclosure; and

FIG. 7 is a flow chart of a method for performing treatment sessionsusing a neurostimulator unit according to one embodiment of thedisclosure.

DETAILED DESCRIPTION

Referring to FIG. 1, a nerve stimulator device 10 includes atranscutaneous electrode pad (not shown), a percutaneous needleelectrode 14, a battery operated neurostimulator unit 16 having a pulsegenerator, and a single lead wire 18 for electrically coupling theneedle electrode 14 to the neurostimulator unit 16. In preferredembodiments, the neurostimulator unit 16 includes dimensions ofapproximately 54 mm in length, approximately 46 mm in width, and a depthof approximately 14 mm and is configured to be removeably attached tothe electrode pad which is adhesively applied to a patient's skin. Inother words, the neurostimulator unit 16 is sized and configured forcomfortable placement of the unit adjacent the heel or ankle area of thepatient.

Referring to FIGS. 3-4, the transcutaneous electrode pad 12 includes anattachment mechanism 20 on the top surface 13 of the pad 12 and theneurostimulator unit 16 includes a corresponding attachment mechanism 22on the bottom surface 17 of the neurostimulator unit 16 for removeablyattaching and electrically coupling the neurostimulator unit 16 with theelectrode pad 12. In a preferred embodiment, the neurostimulator unit 16includes a female snap connector 22 disposed on the bottom surface 17that connects to a corresponding male connector 20 disposed on the topsurface 13 of the electrode pad 12.

By providing a neurostimulator unit 16 having an integrated pulsegenerator and electrode pad 12 during operation of the stimulator device10, only a single lead 18 is needed to be included in the device 10 toconnect the needle electrode 14 and provide stimulation to thestimulation site. No lead wire is needed to electrically couple theneurostimulator unit 16 and electrode pad 12. This results in a compactsystem having very few parts. The entirety of the system is also able tobe connected to the patient during treatment which provides the patientgreater flexibility in movement during a treatment session. Further, asa hand held pulse generator is not being used, the single lead 18 onlyneeds to be as long as the distance from where the electrode pad 12 isapplied to the skin of the patient to the insertion site of the needleelectrode 14.

In operation, the transcutaneous electrode pad 12 is positioned near aselected stimulation site on the surface of the skin. The percutaneousneedle electrode 14 is then inserted through the skin adjacent the nerveor nerves to be stimulated, i.e., preferably adjacent the tibial nervewhen treating incontinence. The neurostimulator unit 16 is attached tothe transcutaneous electrode pad 12 and the lead wire 18 is connected tothe neurostimulator unit 16 so that the pulse generator is electricallycoupled to both the electrode pad 12 and the needle electrode 14. Whenthe pulse generator is activated to perform a treatment session, currentpulses traverse the stimulation site by passing from the transcutaneouselectrode 12 to the internal percutaneous electrode needle 14.

Referring to FIG. 2, the neurostimulator unit 16 includes a LCD displayor other type of graphic display 30 for displaying operating informationof the unit 16 such as the battery level, time remaining for a treatmentsession, signal strength of the pulse generator, treatment creditsremaining for the unit 16, and a network/computer connection status.Further aspects of the neurostimulator unit may include, for example,operating utilities such as a power button 32 for turning the unit 16 onand off, a toggle control 34 for adjusting the signal strength of thepulse generator, a start button 36 for beginning a treatment session,and a receiver 38 for receiving the lead wire 18 and electricallycoupling the percutaneous electrode 14 to the neurostimulator unit 16.

In alternate embodiments, the graphic display 30 and/or some of theoperating utilities may be either removable or permanently separate fromthe neurostimulator unit 16 to allow for handheld control of the device10. Such a design would provide for further compactness of theneurostimulator unit 16. The handheld unit would then preferablycommunicate with the neurostimulator unit 16 wirelessly using aninfrared, Bluetooth, wireless internet, or other means of wirelessconnection. Alternatively, the handheld unit may include a wiredconnection with the neurostimulator unit 16. Other features of thehandheld unit may include the ability to control multipleneurostimulator units 16 and the ability to time each treatment sessionand notify the patient or administrator with an audio alert at the endof the treatment session.

In another aspect of the disclosure, the neurostimulator unit 16 ispreferably connectable to a computer system for providing a treatmentcredit purchasing system and for monitoring the status and usage of thedevice 10. The neurostimulator unit 16 is preferably operable tocommunicate with the computer system through a universal serial bus(USB) connector or wirelessly by using an infrared, Bluetooth, wirelessinternet, or other means of wireless connection. Alternatively,information may be transferred between the neurostimulator unit 16 andthe computer system using a portable digital storage device such as aUSB flash drive.

In these embodiments, the neurostimulator unit 16 includes amicrocontroller or processor for storing information relating to thecurrent status and past usage of the unit 16 and controlling operationof the device 10. The status and usage information may be transferredfrom the unit 16 to the computer system when the unit 16 is connected tothe computer system. In particular, the microcontroller monitors anumber of treatment credits the neurostimulator unit has available toit. Each available treatment credit corresponds to a treatment session.After a treatment session is completed, the number of availabletreatment credits is decreased. If there are no more treatment creditsavailable to the neurostimulator unit 16, the microcontroller preventsthe neurostimulator unit 16 from performing a treatment session bypreventing activation of the pulse generator. In order for the unit 16to be used in further treatment sessions, additional treatment creditsmust be purchased and transferred to the neurostimulator unit 16.

With reference to the block diagram of FIG. 5, one embodiment of thecircuitry of the neurostimulator unit 16 is disclosed. As describedabove, the neurostimulator unit includes the graphic display 30, powerbutton 32, toggle control 34, start button 36, pulse generator 40,battery 42, USB port 44, and microcontroller 46. The microcontroller 46controls operation of the high voltage supply (DC to DC converter 54)and display of the operational characteristics on the graphic display 30using a series of switches 48, digital-to-analog converters 50,analog-to-digital converters 52, and a DC to DC converter 54. A warningmechanism 56 such as a buzzer or light may be provided for notifying apatient or administrator that a treatment session is completed or aproblem has occurred with the neurostimulator unit 16.

As shown, it is preferred that the USB port 44 is electrically isolatedfrom the remaining components of unit 16 using an isolator 58 andisolated DC to DC converter 60. Other aspects of the unit 16 include apower management chip 62 disposed between the battery 42 andmicrocontroller 46, which uses power from the USB port 44 to charge thebattery 44 connected through a fuse 64 disposed between the battery 42and microcontroller 46. A regulator 66 is provided for maintaining aconstant supply voltage to the USB interface 68 when the USB port 44 isconnected.

Referring to FIG. 6, the computer system includes a customer interface70 for purchasing treatment credits to be used with an appropriateneurostimulator unit 16. It should be understood that the customer couldinclude the patient or a health care professional or office thatadministers treatment sessions to patients, and the terms user,customer, patient, and administrator may be used interchangeably herein.Each customer is set up with a customer account and the customer'sneurostimulator unit or units 16 are then linked to this account. Thecustomer interface 70 is preferably available to the customer through aweb based application accessible from a desktop computer, laptop, tabletcomputer, smartphone, or the like.

As shown in FIG. 6, the customer has several options to choose fromthrough the customer interface 70 such as downloading and purchasingtreatment credits 72, requesting a refund of treatment credits 74,ordering supplies 76 such as electrode pads 12 and needle electrodes 14,accessing account information 78, requesting technical support 80, andone or more links 82 that redirect the user to additional information onthe web such as the manufacturer website.

When the neurostimulator unit 16 is connected to the computer system,the microcontroller is updated, preferably automatically, based on theactions of the customer through the customer interface 70. For example,if the user purchases a treatment credit using the customer interface70, the purchased treatment credit is transferred to the microcontrollerof the neurostimulator unit 16 for providing the user with an additionaltreatment session when the unit 16 is connected to the computer systemor a network connected to the computer system.

Referring to FIG. 7, a method for performing tibial nerve stimulationtreatment sessions using the nerve stimulation device 10 is provided. Itshould be understood that the following steps are generally performed inno particular order and some steps may be omitted. In step 100, the useror customer is provided with a nerve stimulation device 10 having aneurostimulator unit 16 as described substantially above. Preferably,the nerve stimulation device 10 is provided to the customer at a reducedcost which is to be recouped by having the customer pay for using thedevice 10 on a per-treatment session basis. In step 102, the customersigns up for a customer account on the computer system and links thecustomer's one or more neurostimulator units 16 with the customeraccount. Preferably, each neurostimulator unit 16 includes a uniqueidentification number and the neurostimulator unit 16 is linked to thecustomer account by providing the appropriate unique identificationnumber.

After signing into the customer account, the customer is directed to thecustomer interface 70 and purchases one or more treatment credits instep 104. Each purchased treatment credit preferably includes a uniqueserial number for assisting in tracking usage of the treatment credit.In step 106, the neurostimulator unit 16 is connected to the computersystem through a wireless or hardwire connection as described above fortransferring information between the neurostimulator unit 16 and thecomputer system. In step 108, the neurostimulator unit 16 transmits itsunique identification number to the computer system and the computersystem verifies that the unit 16 is linked to the customer account.

After verification that the unit 16 is an authorized device for theparticular customer account, the computer system transmits the one ormore treatment credits purchased in step 104 to the neurostimulator unit16 in step 110. Alternatively, the information could be transferredbetween the computer system and the neurostimulator unit using a digitalstorage device such as a flash drive. In addition to transmitting thepurchased treatment credits to the neurostimulator unit 16, informationtransferred to the computer system from the neurostimulator unit 16could include a number of remaining treatment credits, if any, availableto the unit 16, the total number of treatment sessions provided by theunit 16, the status of incomplete treatment sessions performed by theunit 16, usage information of particular treatment credits based on thetreatment credit's unique serial number, battery status, etc. Thisinformation can then be accessed from the customer interface 70 formonitoring the status and usage of the neurostimulator unit 16 whendesired. For example, the usage information would be helpful whenpreparing bills to patients and processing insurance claims.

In step 112, the patient or administrator requests a treatment sessionto be performed using the neurostimulator unit 16. At this point, theunit may or may not be connected to the computer system. In step 114,the neurostimulator unit 16 determines whether a treatment credit isavailable. If it is determined in step 114 that there the unit 16 has nomore available treatment credits, the patient or user must return tostep 104 to purchase additional treatment credits before anothertreatment session may be performed. If a treatment credit is available,the nerve stimulation device 10 performs a treatment session using oneof the treatment credits purchased in step 104 and transferred to theneurostimulator unit in step 116. In performing the treatment session,the unit 16 activates the pulse generator so that current pulsestraverse the stimulation site during the treatment session by passingfrom the transcutaneous electrode 12 to the internal percutaneouselectrode needle 14. After a treatment session is performed, the numberof available treatment credits is reduced by one. Step 112 is thenrepeated when another treatment session is requested.

The foregoing description of preferred embodiments for this disclosurehave been presented for purposes of illustration and description. Theyare not intended to be exhaustive or to limit the invention to theprecise form disclosed. Obvious modifications or variations are possiblein light of the above teachings. The embodiments are chosen anddescribed in an effort to provide the best illustrations of theprinciples of the invention and its practical application, and tothereby enable one of ordinary skill in the art to utilize the inventionin various embodiments and with various modifications as are suited tothe particular use contemplated. All such modifications and variationsare within the scope of the invention as determined by the appendedclaims when interpreted in accordance with the breadth to which they arefairly, legally, and equitably entitled.

What is claimed is:
 1. A method for providing a reusable nervestimulation system to treat incontinence, the method comprising:providing a computer system having a customer interface; providing aneurostimulator unit including: a pulse generator for electricallycoupling to a transcutaneous electrode configured to be applied to skinadjacent a stimulation site of a patient and a percutaneous electrodehaving a leading end for inserting adjacent the stimulation site of apatient, and a microcontroller in communication with the pulse generatorfor monitoring a number of available treatment credits to theneurostimulator unit and for activating the pulse generator during atreatment session when the number of available treatment credits is atleast one; receiving at the computer system a treatment credit requesttransmitted through the customer interface, each treatment creditrequest having purchase information including a number of treatmentcredits purchased, each treatment credit purchased corresponding to anavailable treatment credit; transmitting the number of treatment creditspurchased to the microcontroller of the neurostimulator unit; andadjusting the number of treatment credits available to theneurostimulator unit based on the number of treatment credits purchasedtransmitted to the microcontroller of the neurostimulator unit.
 2. Themethod of claim 1 further comprising: determining whether the number ofavailable treatment credits is at least one; and activating the pulsegenerator based on a treatment session request when it is determinedthat the number of available treatment credits is at least one.
 3. Themethod of claim 1 further comprising: transmitting usage informationfrom the microcontroller to the computer system, the usage informationincluding a number of treatment sessions performed; monitoring the usageinformation of the neurostimulator unit through the computer system; andproviding the usage information to a customer through a customerinterface of the computer system.
 4. The method of claim 1 furthercomprising: providing each treatment credit purchased with a uniqueserial number; monitoring usage information of each treatment creditpurchased at the neurostimulator unit; transmitting the usageinformation from the neurostimulator unit to the computer system foreach treatment credit purchased based on the unique serial number. 5.The method of claim 1 wherein the pulse generator is dimensioned andconfigured to be removeably attached to the transcutaneous electrode. 6.The method of claim 1 wherein the computer system transmits the numberof treatment credits purchased to the microcontroller wirelessly throughone of radio frequency, Bluetooth, infrared, and a wireless internetconnection.
 7. The method of claim 1 wherein the computer systemtransmits the number of treatment credits purchased to themicrocontroller through a universal serial bus connection.
 8. A methodfor providing a reusable nerve stimulation system to treat incontinence,the method comprising: providing at least one neurostimulator unit to acustomer, each neurostimulator unit including: a pulse generator forelectrically coupling to a transcutaneous electrode configured to beapplied to skin adjacent a stimulation site of a patient and apercutaneous needle electrode having a removable leading end forinserting adjacent the stimulation site of the patient, and amicrocontroller in communication with the pulse generator for monitoringa number of available treatment credits to the neurostimulator unit;linking each of the neurostimulator units to a customer account, thecustomer able to access the customer account through a customerinterface of a computer system; receiving at the computer system atreatment credit request from the customer transmitted through thecustomer interface, the treatment credit request having purchaseinformation including a number of treatment credits purchased to bestored in the customer account; connecting at least one of theneurostimulator units to the computer system; transmitting at least oneof the treatment credits purchased from the customer account to themicrocontroller of the connected neurostimulator unit; adjusting thenumber of available treatment credits to the neurostimulator unit andthe number of treatment credits purchased stored in the customer accountbased on the number of treatment credits purchased transmitted to themicrocontroller; and activating the pulse generator upon request by thecustomer to generate current pulses that pass between the transcutaneouselectrode and the percutaneous electrode for providing stimulation tothe stimulation site during one or more treatment sessions, the pulsegenerator able to be activated only when the number of availabletreatment credits to the neurostimulator unit is at least one.
 9. Themethod of claim 8 further comprising: transmitting usage informationfrom the microcontroller to the computer system, the usage informationincluding a number of treatment sessions performed; monitoring the usageinformation of the neurostimulator unit through the computer system; andproviding the usage information to the customer through the customerinterface of the computer system.
 10. The method of claim 8 furthercomprising attaching the pulse generator to the transcutaneous electrodeprior to activating the pulse generator.
 11. The method of claim 10further comprising providing a handheld unit for wirelesslycommunicating the activation request to the neurostimulator unit. 12.The method of claim 8 wherein the connecting of the neurostimulator unitand computer system and the transmitting of the treatment creditspurchased from the customer account to the microcontroller of theconnected neurostimulator unit is performed wirelessly.
 13. The methodof claim 8 further comprising inserting the leading end of thepercutaneous needle electrode adjacent the stimulation site of thepatient, the stimulation site being adjacent a tibial nerve.